Interspinous process implant having deployable wing and method of implantation

ABSTRACT

Systems and method in accordance with an embodiment of the present invention can includes an implant comprising a first wing, a spacer extending from the first wing, and a distraction guide. The distraction guide is arranged in a first configuration to pierce and/or distract tissue associated with adjacent spinous processes extending from vertebrae of a targeted motion segment. The implant can be positioned between the adjacent spinous processes and once positioned, the distraction guide can be arranged in a second configuration. When arranged in a second configuration, the distraction guide can act as a second wing. The first wing and the second wing can limit or block movement of the implant along a longitudinal axis of the implant.

CLAIM OF PRIORITY

U.S. Provisional Patent Application No. 60/663,885 entitled INTERSPINOUSPROCESS IMPLANT HAVING DEPLOYABLE WING AND METHOD OF IMPLANTATION byZucherman et al., filed Mar. 21, 2005 (Attorney Docket No.KLYC-01114US0).

CROSS-REFERENCE TO RELATED APPLICATIONS

This U.S. patent application incorporates by reference all of thefollowing co-pending applications and issued patents:

U.S. Patent Application Ser. No. 60/663,918, entitled “InterspinousProcess Implant Having Deployable Wing and Method of Implantation,”(Attorney Docket Number KLYC-01114US1) filed concurrently;

U.S. patent application Ser. No. 10/850,267, entitled “DistractibleInterspinous Process Implant and Method of Implantation,” filed May 20,2004;

U.S. Pat. No. 6,419,676, entitled “Spine Distraction Implant andMethod,” issued Jul. 16, 2002 to Zucherman, et al.;

U.S. Pat. No. 6,451,019, entitled “Supplemental Spine Fixation Deviceand Method,” issued Sep. 17, 2002 to Zucherman, et al.;

U.S. Pat. No. 6,582,433, entitled “Spine Fixation Device and Method,”issued Jun. 24, 2003 to Yun;

U.S. Pat. No. 6,652,527, entitled “Supplemental Spine Fixation Deviceand Method,” issued Nov. 25, 2003 to Zucherman, et al;

U.S. Pat. No. 6,695,842, entitled “Interspinous Process DistractionSystem and Method with Positionable Wing and Method,” issued Feb. 24,2004 to Zucherman, et al;

U.S. Pat. No. 6,699,246, entitled “Spine Distraction Implant,” issuedMar. 2, 2004 to Zucherman, et al; and

U.S. Pat. No. 6,712,819, entitled “Mating Insertion Instruments forSpinal Implants and Methods of Use,” issued Mar. 30, 2004 to Zucherman,et al.

TECHNICAL FIELD

This invention relates to interspinous process implants.

BACKGROUND OF THE INVENTION

The spinal column is a bio-mechanical structure composed primarily ofligaments, muscles, vertebrae and intervertebral disks. Thebio-mechanical functions of the spine include: (1) support of the body,which involves the transfer of the weight and the bending movements ofthe head, trunk and arms to the pelvis and legs, (2) complexphysiological motion between these parts, and (3) protection of thespinal cord and the nerve roots.

As the present society ages, it is anticipated that there will be anincrease in adverse spinal conditions which are characteristic of olderpeople. By way of example only, with aging comes an increase in spinalstenosis (including, but not limited to, central canal and lateralstenosis), and facet arthropathy. Spinal stenosis results in a reductionforaminal area (i.e., the available space for the passage of nerves andblood vessels) which compresses the nerve roots and causes radicularpain. Humpreys, S. C. et al., Flexion and traction effect on C5-C6foraminal space, Arch. Phys. Med. Rehabil., vol. 79 at 1105 (September1998). Another symptom of spinal stenosis is myelopathy, which resultsin neck and back pain and muscle weakness. Id. Extension and ipsilateralrotation of the neck and back further reduces the foraminal area andcontributes to pain, nerve root compression and neural injury. Id.; Yoo,J. U. et al., Effect of cervical spine motion on the neuroforaminaldimensions of human cervical spine, Spine, vol. 17 at 131 (Nov. 10,1992). In contrast, neck and back flexion increases the foraminal area.Humpreys, S. C. et al., at 1105.

Over time, loss of disk height in the thoracic and lumbar regions, aswell as the cervical region can result in a degenerative cascade withdeterioration of all components of a motion segment resulting in segmentinstability and ultimately in spinal stenosis. During the process ofdeterioration, disks can become herniated and/or become internally tornand chronically painful. When symptoms seem to emanate from bothanterior (disk) and posterior (facets and foramen) structures, patientscannot tolerate positions of extension or flexion.

Pain associated with stenosis can be relieved by medication and/orsurgery. It is desirable to eliminate the need for major surgery for allindividuals, and in particular, for the elderly.

Accordingly, a need exists to develop spine implants that alleviate paincaused by spinal stenosis and other such conditions caused by damage to,or degeneration of, the spine. Such implants would distract, or increasethe space between, the vertebrae to increase the foraminal area andreduce pressure on the nerves and blood vessels of the spine.

A further need exists for development of a minimally invasive surgicalimplantation method for spine implants that preserves the physiology ofthe spine.

Further, a need exists for an implant that accommodates the distinctanatomical structures of the spine, minimizes further trauma to thespine, and obviates the need for invasive methods of surgicalimplantation. Additionally, a need exists to address adverse spinalconditions that are exacerbated by spinal extension.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of an implant including a spacer having atear-drop shaped cross-section, a distraction guide, a first wing, and asecond wing connectable with the distraction guide.

FIG. 1B is a perspective view of an implant including a rotatable spacerhaving an elliptical cross-section, a distraction guide, a first wing,and a second wing connectable with the distraction guide.

FIG. 2A is a perspective view of an implant in accordance with anembodiment of the present invention including a main body and an insert,the main body having a distraction guide, a spacer, and a first wing.

FIG. 2B is a perspective view of the implant of FIG. 2A wherein theinsert is positioned within the main body, causing the distraction guideassociated with the main body to limit or block movement of the implantwhen positioned between adjacent spinous processes.

FIG. 3A is a side view of the main body of the implant of FIGS. 2A and2B positioned between adjacent spinous processes.

FIG. 3B is a side view of the implant of FIG. 3A wherein the insert ispositioned within the main body.

FIG. 4 is a perspective view of an implant in accordance with analternative embodiment wherein the main body includes hooks to limitrelative movement of adjacent spinous processes during flexion motion.

FIG. 5 is a side view of the implant of FIG. 4 positioned betweenadjacent spinous processes and arranged so that the hooks confine theadjacent spinous processes.

FIG. 6A is a perspective view of still another embodiment of an implantin accordance with the present invention, wherein a first section and asecond section of a distraction guide are deployable to form a secondwing.

FIG. 6B is a perspective view of the implant of FIG. 6A wherein theinsert is positioned within the main body, causing the first section andthe second section of the distraction guide to deploy.

FIG. 7A is a perspective view of a still further embodiment of animplant in accordance with the present invention including a rotatablespacer.

FIG. 7B is a perspective view of the implant of FIG. 7A wherein theinsert is positioned within a central body so that the distraction guidedeploys as a second wing.

FIG. 7C is a cross-sectional side view of distraction guide of FIG. 7A.

FIG. 7D is a cross-sectional side view of distraction guide of FIG. 7B.

FIG. 8 is a side view of the implant of FIGS. 7A-7D positioned betweenadjacent spinous processes.

FIG. 9A is a side view of an alternative embodiment of the implantpositioned between adjacent spinous processes.

FIG. 9B is a partial cross-section side view of the implant of FIG. 9Ashowing deployable winglets disposed within a distraction guide of theimplant.

FIG. 9C is a partial cross-sectional side view of the implant of FIG. 9Bwherein the winglets deployed.

FIG. 10A is a side view of an alternative embodiment of the implantpositioned between adjacent spinous processes.

FIG. 10B is a side view of the implant of FIG. 10A positioned betweenadjacent spinous processes wherein the winglets deployed.

FIG. 10C is a partial cross-sectional end view of the implant of FIG.10A showing deployable winglets disposed within a distraction guide ofthe implant.

FIG. 10D is a partial cross-sectional end view of the implant of FIGS.10A-10C showing the winglets deployed so that the winglets extend fromthe distraction guide of the implant.

FIG. 10E is an end view of the implant of FIGS. 10A-10D showing thedistraction guide and the deployed winglets relative to the distractionguide.

FIG. 11A is a partial cross-sectional end view of an alternativeembodiment of an implant in accordance with the present inventionincluding an alternative actuator arrangement.

FIG. 11B is an partial cross-sectional end view of the implant of FIG.11A showing the winglets deployed so that the winglets extend from thedistraction guide of the implant.

FIG. 12A is a partial cross-sectional end view of still anotherembodiment of an implant in accordance with the present invention havingan alternative actuator arrangement wherein the winglets comprise twohinged portions.

FIG. 12B is a partial cross-sectional end view of the implant of FIG.12A showing the winglets deployed so that the winglets extend from thedistraction guide of the implant.

FIG. 13 is a partial cross-sectional end view of a still furtherembodiment of an implant in accordance with the present inventionwherein implants are arranged at adjacent motion segments.

FIG. 14 illustrates an embodiment of a method for implanting the implantof FIGS. 2A-8 between adjacent spinous processes in accordance with thepresent invention.

FIG. 15A illustrates an embodiment of a method for implanting theinterspinous implant of FIGS. 2A-8 between adjacent spinous processes inaccordance with the present invention.

FIG. 15B illustrates an embodiment of a method for implanting theinterspinous implant of FIGS. 9A-13 between adjacent spinous processesin accordance with the present invention.

DETAILED DESCRIPTION

Interspinous Implants

FIG. 1A is a perspective view of an implant as described in U.S. patentapplication Ser. No. 10/850,267, filed May 20, 2004, incorporated hereinby reference. The implant 100 comprises a first wing 130, a spacer 120,and a lead-in tissue expander (also referred to herein as a distractionguide) 110. The distraction guide 110 in this particular embodiment iswedge-shaped, i.e., the implant has an expanding cross-section from aproximal end of the implant 100 to a region 150 where the guide 110joins with the spacer 120 (referencing for the figures is based on thepoint of insertion of the implant between spinous processes). As such,the distraction guide 110 functions to initiate distraction of the softtissue and the spinous processes when the implant 100 is surgicallyinserted between the spinous processes. It is to be understood that thedistraction guide 110 can be pointed and the like, in order tofacilitate insertion of the implant 100 between the spinous processes ofadjacent cervical vertebrae. It is advantageous that the insertiontechnique disturb as little of the bone and surrounding tissue orligaments as possible in order to reduce trauma to the site and promoteearly healing, and prevent destabilization of the normal anatomy. Forembodiments such as those of FIGS. 1A and 1B, there is no requirement toremove any of the bone of the spinous processes and no requirement tosever, or remove from the body, ligaments and tissues immediatelyassociated with the spinous processes. For example, it is unnecessary tosever the supraspinal ligament of the lower vertebrae or the ligamentumnuchae (which corresponds to the supraspinal ligament) which partiallycushions the spinous processes of the upper cervical vertebrae.

As can be seen, the spacer 120 can be teardrop-shaped in cross-sectionperpendicular to a longitudinal axis 125 of the implant 100. In thisway, the shape of the spacer 120 can roughly conform to a wedge-shapedspace, or a portion of the space, between adjacent spinous processeswithin which the implant 100 is to be positioned. As shown in FIG. 1A,the spacer 120 (and the first wing 108) is shaped to accommodate theanatomical form or contour of spinous processes (and/or laminae) ofpreferably the C6 and C7 vertebra for placement between such spinousprocesses (i.e., the C6-C7 motion segment). The same shape or variationsof this shape can be used to accommodate other motion segments, forexample in the thoracic or lumbar regions. In other embodiments thespacer 120 can have alternative shapes such as circular, wedge, oval,ovoid, football, and rectangular with rounded corners, and other shapes.The shape of the spacer 120 can be selected for a particular patient sothat the physician can position the implant 100 as close as possible tothe anterior portion of the surface of the spinous process. The shapeselected for the spacer 120 can affect the contact surface area of theimplant 100 and the spinous processes that are to be subject todistraction. Increasing the contact surface area between the implant 100and the spinous processes can distribute a load force between thespinous frame and the implant 100.

The first wing 130 is likewise teardrop-shaped in cross-sectionperpendicular to a longitudinal axis 125 of the spacer 120 anddistraction guide 110. The dimensions of the first wing 130 can belarger than that of the spacer 120, particularly along the axis of thespine, and can limit or block lateral displacement of the implant 100 inthe direction of insertion along the longitudinal axis 125. As with thespacer 120, the first wing 130 can have other cross-sectional shapes,such as elliptical, wedge, circular, oval, ovoid, football, andrectangular with rounded corners and other shapes.

The implant 100 of FIG. 1A further includes an adjustable wing 160 (alsoreferred to herein as a second wing) separate from the distraction guide110, the spacer 120 and the first wing 130. The second wing 160 isconnectable with the distraction guide 110 (and/or the spacer 120) oncethe implant 100 is positioned between adjacent spinous processes. Thesecond wing 160, similar to the first wing 130, can limit or blocklateral displacement of the implant 100, however displacement is limitedor blocked in the direction opposite insertion. When both the first wing130 and the second wing 160 are connected with the implant 100 and theimplant 100 is positioned between adjacent spinous processes, a portionof the spinous processes can be sandwiched between the first wing 130and the second wing 160, limiting displacement along the longitudinalaxis 125. As can be seen, the second wing 160 can be teardrop-shaped incross-section. A lip 180 defining a space 170 through the second wing160 allows the second wing 160 to pass over the distraction guide 110 tomeet and connect with the distraction guide 110 and/or the spacer 120.The second wing 160 is then secured to the distraction guide 110 and/orthe spacer 120. The second wing 160, can be designed to beinterference-fit onto the spacer 120 or a portion of the distractionguide 110 adjacent to the spacer 120. Where the second wing 160 isinterference-fit, there is no additional attachment device to fasten thesecond wing 160 relative to the remainder of the implant 100.

Alternatively, various fasteners can be used to secure the second wing160 relative to the remainder of the implant 100. For example, FIG. 1Aillustrates an embodiment of an implant 100 including a teardrop-shapedsecond wing 160 having a tongue 158 at the posterior end of the secondwing 160. A bore 155 is disposed through the tongue 158, and is alignedwith a corresponding bore 156 on the spacer 120 when the second wing 160is brought into position by surgical insertion relative to the rest ofthe implant 100. A threaded screw 154 can be inserted through thealigned bores 155,156 in a posterior-anterior direction to secure thesecond wing 160 to the spacer 120. The direction of insertion from aposterior to an anterior direction has the screw 154 engaging the bores155,156 and the rest of the implant 100 along a direction that isgenerally perpendicular to the longitudinal axis 125. This orientationis most convenient when the physician is required to use a screw 154 tosecure the second wing 160 to the rest of the implant 100. The secondwing 160 can further be secured to the spacer 120 by some othermechanism, for example such as a flexible hinge (not shown) with aprotrusion that engages an indentation of one of the distraction guide110 and the spacer 120. Alternatively, the second wing 160 can besecured to one of the distraction guide 110 and the spacer 120 by stillsome other mechanism.

FIG. 1B is a perspective view of an implant as described in U.S. Pat.No. 6,695,842 to Zucherman, et al., incorporated herein by reference.The implant 200 has a main body that includes a spacer 220, a first wing230, a lead-in tissue expander 210 (also referred to herein as adistraction guide) and an alignment track 203. The main body of theimplant 200 is inserted between adjacent spinous processes and remainsin place (where desired) without attachment to the bone or ligaments.

The distraction guide 210 includes a tip from which the distractionguide 210 expands, the tip having a diameter sufficiently small suchthat the tip can pierce an opening in an interspinous ligament and/orcan be inserted into a small initial dilated opening. The diameterand/or cross-sectional area of the distraction guide 210 graduallyincreases until it is substantially similar to the diameter of thespacer 220. The tapered front end eases the ability of a physician tourge the implant 200 between adjacent spinous processes. When urging themain body of the implant 200 between adjacent spinous processes, thefront end of the distraction guide 210 distracts the adjacent spinousprocesses and dilates the interspinous ligament so that a space betweenthe adjacent spinous processes is approximately the diameter of thespacer 220.

As shown in FIG. 1B, the spacer 220 is elliptically shaped incross-section, and can swivel so that the spacer 220 can self-alignrelative to the uneven surfaces of the spinous processes. Self-alignmentcan ensure that compressive loads are distributed across the surface ofthe bone. As contemplated in Zucherman '842, the spacer 220 can have,for example, a diameter of six millimeters, eight millimeters, tenmillimeters, twelve millimeters and fourteen millimeters. Thesediameters refer to the height by which the spacer 220 distracts andmaintains apart the spinous process. For an elliptically shaped spacer220, the selected height (i.e., diameter) is the minor dimensionmeasurement across the ellipse. The major dimension is transverse to thealignment of the spinous process, one above the other.

The first wing 230 has a lower portion 231 and an upper portion 232. Theupper portion 232 is shaped to accommodate the anatomical form orcontour of spinous processes (and/or laminae) of preferably the L4 (foran L4-L5 placement) or L5 (for an L5-S1 placement) vertebra. The sameshape or variations of this shape can be used to accommodate othermotion segments, such as motion segments in the cervical and thoracicregions. The lower portion 231 can also be rounded to accommodate thespinous processes. The lower portion 231 and upper portion 232 of thefirst wing 230 act as a stop mechanism when the implant 200 is insertedbetween adjacent spinous processes. The implant 200 cannot be insertedbeyond the surfaces of the first wing 230. Additionally, once theimplant 200 is inserted, the first wing 230 can prevent someside-to-side, or posterior-to-anterior movement of the implant 200.

As with the implant 100 of FIG. 1A, the implant 200 of FIG. 1B furtherincludes a second wing 260. Similar to the first wing 230, the secondwing 260 includes a lower portion 261 and an upper portion 262 sizedand/or shaped to accommodate the anatomical form or contour of thespinous processes and/or lamina. The second wing 260 can be secured tothe main body of the implant 200 with a fastener 254. The second wing260 also has an alignment tab 268. When the second wing 260 is initiallyplaced on the main body of the implant 200, the alignment tab 268engages the alignment track 203. The alignment tab 268 slides within thealignment track 203 and helps to maintain the adjustable wing 260substantially parallel with the first wing 230. When the main body ofthe implant 200 is inserted into the patient and the second wing 260 hasbeen attached, displacement along the longitudinal axis 225 in eitherthe direction of insertion or the direction opposite insertion can belimited or blocked. Further, the second wing 260 also can prevent someside-to-side, or posterior-to-anterior movement.

For both the implant 100 of FIG. 1A and the implant 200 of FIG. 1B,where a second wing 160,260 is connected with the implant 100,200 afterthe implant 100,200 is positioned between the spinous processes, aprocedure for positioning such an implant 100,200 and subsequentlyconnecting the second wing 160,260 with the implant 100,200 can requirea bilateral approach wherein a physician must access both sides of theinterspinous ligament, a first side to pierce and/or distract theinterspinous ligament and position the implant 100,200 so that themovement in the direction of insertion is satisfactorily limited by thefirst wing 130,230, and a second side to attach the second wing 160,260such that movement in the direction opposite insertion is satisfactorilylimited by the second wing 160,260.

Implants having Deployable Second Wing

Referring to FIGS. 2A through 3B, implants 300 and methods forpositioning such implants in accordance with the present invention can,in an embodiment, include a deployable second wing 360 associated with amain body 301 such that the second wing 360 can be deployed with aphysician needing only to access a first side of spinous processes tolimit or block movement along the longitudinal axis 325.

As shown in FIG. 2A, the implant 300 includes a main body 301 having afixed spacer 320 and a distraction guide 310. The distraction guide 310comprises a first winglet (also referred to herein as an upper winglet)312 and a second winglet (also referred to herein as a lower winglet)314, and when arranged in a first configuration can include a tip fromwhich the distraction guide 310 expands, the tip having a diametersufficiently small such that the tip can pierce an opening in aninterspinous ligament and between spinous processes and/or can beinserted into a small initial dilated opening. The diameter and/orcross-sectional area of the distraction guide 310 is then graduallyincreased until it is substantially similar to the diameter of thespacer 320. In this respect, the distraction guide 310 of FIG. 2A canresemble a distraction guide as described above when arranged in thefirst configuration. The winglets 312,314 can be hinged or otherwisepivotably connected with the main body 301 such that the winglets312,314 can be arranged in a second configuration (FIG. 2B) once theimplant 300 is positioned between spinous processes. In a secondconfiguration one or both of the winglets 312,314 abut at least one ofthe spinous processes and/or related tissues when urged in a directionopposite from insertion, thereby limiting motion along the longitudinalaxis 325. Thus when arranged in a second configuration, the distractionguide 310 becomes a second wing 360, as shown in FIG. 2B.

The implant 300 includes an insert 370 having an insert body 372 and afirst wing 330. As shown in FIG. 2B, the insert 370 can be mated withthe main body 301 to arrange the distraction guide 310 of the implant300 in the second configuration, thereby deploying the second wing 360.To facilitate mating of the main body 301 and the insert 370, the spacer320 includes a cavity sized and shaped for receiving the insert body 372and accessible from a distal end of the main body 301. A portion of theupper winglet 312 and the lower winglet 314 can extend at leastpartially into the cavity so that when the insert body 372 is receivedwithin the cavity, the insert body 372 displaces the portions, causingthe distraction guide 310 to be arranged in the second configuration. Inthe embodiment shown, the upper winglet 312 and the lower winglet 314each include a lever 316,318 comprising a curved protrusion thatprotrudes into the cavity when the distraction guide 310 is in the firstconfiguration. As the insert body 372 of the insert 370 fills thecavity, the insert body 372 contacts the first lever 316 and the secondlever 318, applying a force to the first lever 316 and the second lever318 which translates into a pivoting motion of the hinged upper winglet312 and the hinged lower winglet 314. The insert body 372 can optionallyhave a tapered proximal end 374 having a first groove 376 and a secondgroove 378 corresponding to the first lever 316 and the second lever318, respectively. The tapered shape of the proximal end 374 allows theupper winglet 312 and lower winglet 314 to be deployed gradually, fullydeploying as the insert body 372 is fully seated within the cavity. Themain body 301 is shown including a flange 303 in which is formed notches305 to receive an insertion tool (not shown), for example. As the insertbody 372 is seated within the cavity, an upper tab 332 and a lower tab331 of the first wing 330 seats within cut-outs 322 of the flange 303.

Referring to FIG. 3A, the main body 301 of the implant 300 is shownpositioned between adjacent spinous processes of the targeted motionsegment. The motion segment shown is within the lumbar region, but inother embodiments, particularly where a fixed spacer 320 is used,implants 300 in accordance with the present convention can be positionedat motion segments of the thoracic and cervical region. The main body301 is positioned as shown by initially approaching the interspinousligament between the upper and lower adjacent spinous processes 2,4through an opening to the right of the interspinous ligament, roughlyposterior to the right inferior articular facet 6 of the vertebrae fromwhich the upper spinous process 2 extends. The main body 301 can beassociated with one or more insertion tools (not shown), and thedistraction guide 310 can be arranged in the first configuration. Thetip of the distraction guide 310 is positioned roughly adjacent to apoint along the interspinous ligament, and the distraction guide 310 isthen urged through the interspinous ligament, piercing the interspinousligament and/or separating and distracting fibers of the interspinousligaments. The main body 301 is then urged through the interspinousligament until the spacer 320 is positioned between the adjacent spinousprocesses 2,4 so that the spacer 320 supports a load applied by thespinous processes 2,4.

Referring to FIG. 3B, once the implant 300 is positioned as desired, theinsertion tools can be removed from the opening and the insert 370 canbe positioned at the distal end of the main body 301. The insert body372 can be urged into the cavity within the main body 301 until theproximal end 374 of the insert body 372 contacts the first lever 316 andthe second lever 318. The insert 370 can then be further urged along thelongitudinal axis 325 so that the insert body 372 urges the first lever316 and the second lever 318 away from the insert body 372, causing theupper winglet 312 and the lower winglet 314 to pivot about the firsthinge 313 and the second hinge 315, respectively. As the first lever 316and the second lever 318 are displaced from the cavity, the first lever316 and the second lever 318 are guided along corresponding grooves376,378 of the tapered proximal end 374. As the insert body 372 seatswithin the cavity of the main body 301, the upper winglet 312 and thelower winglet 314 deploy as a second wing 360. The insertion tool can beremoved from the incision once the insert body 372 is seated within themain body 301. As can be seen a portion of the upper spinous process anda portion of the lower spinous process are sandwiched between the firstwing 330 and the second wing 360, limiting motion along the longitudinalaxis 325.

Implants and methods for positioning such implants between spinousprocesses in accordance with the present invention are not meant to belimited to embodiments as described above and otherwise herein, butrather are meant to include any implant having a second wing deployableby urging an insert within a main body positioned between adjacentspinous processes. Myriad different variations may be readily apparentto one of ordinary skill in the art. For example, in an alternativeembodiment, the main body 301 of the implant 300 of FIGS. 2A through 3Bcan include a lower winglet 314 pivotably associated with the main body301 while an upper winglet 312 is fixedly associated with the main body301. An insert 370 can be adapted to deploy only the lower winglet 314when seated within the cavity of the main body 301.

In other embodiments, a first wing 310 can extend from the main body 301rather than, or in addition to, a first wing extending from the insert370. When the main body 301 is initially positioned between the adjacentspinous processes, movement of the main body 301 along the longitudinalaxis 325 can be limited in the direction of insertion. As the first wing310 extending from the main body 301 contacts one or both of theadjacent spinous processes, further movement of the main body 301 in thedirection of insertion can be limited or blocked. The first wing 310 canthus act as a hard stop, allowing the main body 301 to be positionedwithout requiring a position of the main body 301 along the spinousprocesses to be estimated, thereby easing implantation.

Referring to FIG. 4, in still further embodiments implants 400 inaccordance with the present invention can include one or both of a firstengagement element (also referred to herein as an upper hook) 480 and asecond engagement element (also referred to herein as a lower hook) 482for limiting flexion motion in a motion segment. For example, similarhooks have been described in greater detail in U.S. Pat. No. 6,451,019issued Sep. 17, 2002 to Zucherman et al. and U.S. Pat. No. 6,652,527issued Nov. 25, 2003 to Zucherman et al., both incorporated herein byreference. Implants in accordance with the present invention can includesuch arrangements. The implant 400 shown in FIGS. 4 and 5 includes anupper hook 480 extending from an upper connection rod 484 rotatablyassociated with the main body 401 and a lower hook 482 extending from alower connection rod 486 rotatably associated with the main body 401.Alternatively, the connection rods 484,486 can be fixedly associatedwith the main body 401. The hooks 480,482 include tapered proximal ends481,483 that act as lead-in tissue expanders to distract interspinousligaments of the motion segments above and below the targeted motionsegment. As the main body 401 is positioned between adjacent spinousprocesses, the tapered proximal ends 481,483 of the upper and lowerhooks 480,482 can likewise pierce and/or distract interspinous ligamentsso that the upper and lower hooks 480,482 can be properly positioned tolimit or restrain flexion motion of the targeted motion segment when themain body 401 is in place. As shown, the hooks 480,482 can be pivotablyassociated with the connection rods 484,486 so that the hooks 480,482can be rotated relative to the connection rods 484,486, thereby allowinga physician to improve contact and spread loads between the hooks480,482 and corresponding spinous processes 2,4. The rotatable upperconnection rod 484 and lower connection rod 486 can provide flexibilityin placement, so that where an anatomy varies between patients andvaries between motion segments such that the arrangement of a minordimension and major dimension of the implant 400 about the longitudinalaxis 425 varies, the implant 400 can be accommodated.

FIG. 5 is a posterior view of the implant 400 positioned betweenadjacent spinous processes 2,4 and having an upper hook 480 and a lowerhook 482 arranged so that both flexion and extension is limited asdesired. Further, the second wing 460 is deployed to limit movement ofthe implant 400 along the longitudinal axis 425. The upper hook 480 andthe lower hook 482 prevent movement along the longitudinal axis 425 inthe direction opposite insertion, making a first wing unnecessary.

Referring to FIGS. 6A and 6B, in still other embodiments implants 500and methods for positioning such implants 500 between spinous processesin accordance with the present invention can include a distraction guide510 wherein portions of the distraction guide 510 can be extended fromthe distraction guide 510 to form an upper winglet 512 and a lowerwinglet 514, respectively, of a second wing 560 by positioning an insert570 within a cavity of the main body 501. This is in contrast to theabove embodiment where the entire distraction guide is formed by thewinglets. In this embodiment, the winglet 512,514 extend out the side ofthe distraction guide 510. When not extended, as seen in FIG. 6A, thewinglet 512,514 partially form the sides of the distraction guide 510.Such embodiments are contemplated to be useful where it is desired thatthe second wing 560 have a limited height relative to implants 300,400as described above where the entire distraction guide 310 is deployed(see FIG. 2A through 3B). For example, where implants 500 are to bepositioned at adjacent motion segments, it can be desired that thesecond wings 560 of the implants 500 do not interfere with one anotherimplant, for example during an extension motion when compressive loadsare applied to the implants 500. As with implants described above, oneof ordinary skill in the art can appreciate the myriad differentvariations of the implant 500 of FIGS. 6A and 6B. For example, inalternative embodiments the upper winglet 512 and the lower winglet 514can have some other shape. For example, the positions of the upperwinglet 512 and lower winglet 514 are staggered so that implants 500positioned at adjacent motion segments can be more easily positionedwithout interfering with one another. Such staggering can alsoaccommodate anatomies where one of the upper and lower spinal processesis wider than the other. With staggering, for example, the upper winglet512 can be pivotably mounted on the distraction guide 510 at a positionless distant from the distraction end 511 than the location where thelower winglet 514 is pivotably mounted on the distraction guide 510. Instill other embodiments, the upper winglet 512 and the lower winglet 514can have some other shape.

Referring to FIGS. 7A through 8, in still further embodiments ofimplants 600 in accordance with the present invention, the main body 601can include a hollow central body 605 (shown in FIGS. 7C and 7D)extending from a first wing 630. A rotatable spacer 620 is disposedabout the hollow central body 605. The implant 600 can include a spacer620 that resembles spacers, for example, as described above in FIG. 1B.A distraction guide 610 can extend from the hollow central body 605 andcan include an upper winglet 612 and a lower winglet 614, one or both ofwhich can be pivotably associated with a main portion 611 of thedistraction guide 610 so that the upper winglet 612 and/or the lowerwinglet 614 can be deployed as a second wing 660. A pin 606 can beinserted into the hollow central body 605 to deploy the second wing 630.Referring to FIG. 7B, once the pin 606 is seated within the main body601, the upper winglet 612 and the lower winglet 614 can be pivoted awayfrom each other so that the upper winglet 612 and the lower winglet 614limit or block motion along the longitudinal axis 625 in the directionopposite from insertion. The upper winglet 612 and the lower winglet 614thus act as a second wing 660.

Referring to the partial cross-sections of FIGS. 7C and 7D, in anembodiment the distraction guide 610 can include a cup 616 structuresized and arranged to receive the pin 606. Bar structures 618,619 can bepivotably connected between the cup structure 616 and one or both of theupper winglet 612 and the lower winglet 614 so that when a force isapplied to the cup structure 616 by the pin 606, the force is furthertransferred to the upper winglet 612 and the lower winglet 614, causingthe upper winglet 612 and the lower winglet 614 to pivot on hinges613,615 associated with the main portion 611 of the distraction guide610 so that the second wing 660 is deployed. As can be seen, the pivotpoints 613,615 of the upper winglet 612 and the lower winglet 614 arearranged proximally relative to the mount points 617,619 of the barstructures 618,619, causing the upper winglet 612 and the lower winglet614 to pivot away from one another when the mount points 617,619 areurged together by the insertion of the pin 606 (as seen in FIG. 7D). Inother embodiments, the upper winglet 612 and the lower winglet 614 canbe caused to pivot away from one another using some other mechanism.Implants in accordance with the present invention are not intended to belimited to such second wing deployment mechanisms as are described indetail herein.

Referring to FIG. 8, the implant 600 is shown positioned betweenadjacent spinous processes 2,4. The second wing 660 as shown is sizedsuch that when arranged in a first configuration (i.e., as a distractionguide 610) the upper winglet 612 and the lower winglet 614 do not extendundesirably into the adjacent tissues. However, the upper winglet 612and the lower winglet 614 can be sized and shaped other than as shown inFIG. 8. The upper winglet 612 and the lower winglet 614 need only besized and shaped such that when arranged in a second configuration, theupper and lower winglets 612,614 limit or block movement along thelongitudinal axis 625 in a direction opposite from insertion.

FIGS. 9A through 9C illustrate a further embodiment of an implant 700 inaccordance with the present invention arranged between adjacent spinousprocesses 2,4. In such an embodiment, upper and lower winglets 712,714can be disposed within the distraction guide 710 and can be deployed byactuating an actuator arrangement including a shaft connected with a cam707, the shaft having an engageable head 706, or alternatively includingsome other mechanism such as a gear. As can be seen in FIG. 9A theimplant 700 can be disposed between adjacent spinous processes 2,4 asdescribed above in reference to FIG. 3. The distraction guide 710 of theimplant 700 can be employed to pierce and/or distract an interspinousligament 6 connected between the adjacent spinous process 2,4. Theimplant 700 can then be urged between the spinous processes 2,4 so thatthe distraction guide 710 further distracts the interspinous ligament 6to form a space within which a spacer 220 can be disposed. In theembodiment shown, the spacer 220 can pivot about a central bodyextending from the first wing 230 of the implant 700. The first wing 230limits and/or blocks movement along a longitudinal axis 725 of theimplant 700 in the direction of insertion.

Once the implant 700 is arranged as desired, the actuator arrangementcan be actuated to deploy the upper and lower winglets, 712,714, therebyforming a second wing 760 as shown in FIG. 9C. The second wing 760limits and/or blocks movement along the longitudinal axis 725 in adirection opposite the direction of insertion. With the second wing 760deployed, the adjacent spinous processes 2,4 are at least partiallydisposed between the wings 730,760, preventing the implant 800 frombecoming undesirably dislodged from the space between the adjacentspinous processes 2,4. As shown in FIG. 9C, the first wing 730 and thesecond wing 760 can be arranged sufficiently far apart that the adjacentspinous processes 2,4 can move relative to one another slightly (e.g.,laterally—such as during a twisting motion), allowing the patientgreater flexibility of movement.

FIGS. 9B and 9C are partial cross-sectional posterior views of theimplant 700 shown in FIG. 9A. In an embodiment, the deployable winglets712,714 can be extended from the distraction guide 710 using an actuatorarrangement comprising a shaft 707 and cam 716. The cam 716 can berotated to force the winglets 712,714 to pivot outward from thedistraction guide 710. As shown, the winglets 712,714 are at leastpartially disposed within a cavity of the distraction guide 710.

FIGS. 10A through 10E illustrate a still further embodiment of animplant 800 in accordance with the present invention arranged betweenadjacent spinous processes 2,4. In such an embodiment, upper and lowerwinglets 812,814 can be disposed within the distraction guide 810 andcan be deployed by actuating an actuator arrangement including a screw807 having an engageable head 806, or alternatively including some othermechanism such as a gear. As can be seen in FIG. 10A the implant 800 canbe disposed between adjacent spinous processes 2,4 as described above inreference to FIG. 3. The distraction guide 810 of the implant 800 can beemployed to pierce and/or distract an interspinous ligament 6 connectedbetween the adjacent spinous process 2,4. The implant 800 can then beurged between the spinous processes 2,4 so that the distraction guide810 further distracts the interspinous ligament 6 to form a space withinwhich a spacer 220 can be disposed. In the embodiment shown, the spacer220 can pivot about a central body extending from the first wing 230 ofthe implant 800. The first wing 230 limits and/or blocks movement alonga longitudinal axis 825 of the implant 800 in the direction ofinsertion.

Once the implant 800 is arranged as desired, the actuator arrangementcan be actuated to deploy the upper and lower winglets, 812,814, therebyforming a second wing 860 as shown in FIG. 9B. The second wing 860limits and/or blocks movement along the longitudinal axis 825 in adirection opposite the direction of insertion. With the second wing 860deployed, the adjacent spinous processes 2,4 are at least partiallydisposed between the wings 830,860, preventing the implant 800 frombecoming undesirably dislodged from the space between the adjacentspinous processes 2,4. As shown in FIG. 9B, the first wing 830 and thesecond wing 860 can be arranged sufficiently far apart that the adjacentspinous processes 2,4 can move relative to one another slightly (e.g.,laterally—such as during a twisting motion), allowing the patientgreater flexibility of movement.

FIGS. 10C and 10D are partial cross-sectional end views of the implant800 shown in FIGS. 10A and 10B. In an embodiment, the deployablewinglets 812,814 can be extended from the distraction guide 810 using anactuator arrangement comprising a screw 806 and threaded collar 816. Thethreaded collar 816 can be driven along the screw 806 to force thewinglets 812,814 to pivot outward from the distraction guide 810. Asshown, the winglets 812,814 are at least partially disposed within acavity of the distraction guide 810. The winglets 812,814 are pivotablyconnected with the threaded collar 816 at an upper pivot point 817 and alower pivot point 819. Pins 813,815 or other obstruction devices can bedisposed within the cavity and arranged so that the pins 813,815 do notinterfere with the arrangement of the winglets 812,814 in a nested, orundeployed, position. However, as the threaded collar 816 travels alongthe screw 806 in a posterior-to-anterior direction, the inner surface ofthe winglets 812,814 contact the pins 813,815 and the winglets 812,814pivot away from the distraction guide 810. If desired the winglets812,814 can be spring biased against the posts 813,815 such that in thenested positions and in any deployed position the winglets 812,814 areheld against the posts 813,815.

As shown in FIGS. 10D and 10E, when the threaded collar 816 has traveleda distance along the screw 806, the winglets 812,814 are deployed toform a second wing 860. The winglets 812,814 extend along a significantportion of the outer surface of the spinous processes 2,4. When urgedalong the longitudinal axis 825 in a direction opposite the direction ofinsertion, the winglets 812,814 contact the adjacent spinous processes2,4 and resist further movement in said direction. FIG. 10E is an endview of the implant 800 with the second wing 860 deployed. As shown, thescrew head 806 extends from the distraction guide 810; however, whenimplemented, it is preferable for the screw head 806 to be either flushwith the surface of the distraction guide 810 or slightly receded fromthe surface of the distraction guide 810 so that movement of the implant800 is not obstructed during distraction of the interspinous ligament 6and/or the spinous processes 2,4. The screw head 806 is shown extendingfrom the distraction guide 810 to demonstrate possible arrangementrelative to the proximal end of the distraction guide 810.

FIGS. 11A and 11B illustrate yet another embodiment of the implant 900having an alternative actuation arrangement. In such an embodiment, thewinglets 912,914 can be reversed in arrangement so that the winglets912,914 are deployed by urging the threaded collar 916 toward the screwhead 806. FIGS. 12A and 12B illustrate a still further embodiment of theimplant 1000 having an alternative actuation arrangement. In suchembodiments, the winglets 1012,1014 include two hinged portions, eachwinglet 1012,1014 folding outward to form a portion of a second wing1060. The second wing 1060 does not extend as far along the axis of thespine, i.e. the total height of the second wing 1060 along the spine issmaller than previous embodiments. A reduced second wing height can beadvantageous where implants are positioned at adjacent motion segments,thereby preventing undesired contact of adjacent implants.

As mentioned above, in other embodiments in accordance with the presentinvention, the winglets can be deployed from the distraction guide usinga mechanism other than a screw and threaded collar. For example, one ormore gears can be employed. Further, in still other embodiments theupper and lower winglets can have a shape along other than those shapesshown in FIGS. 10A through 12B. The invention is not intended to belimited to winglets having shapes such as shown. In still furtherembodiments, such as shown in FIG. 13, the implant 1100 can include onlyone of the upper and lower winglets. For example, where implants arepositioned at adjacent motion segments it can be advantageous to have alower winglet 814, thereby preventing undesired contact of adjacentimplants 1100. As will be obvious to one of ordinary skill in the art,myriad different actuation arrangements can be employed to form a secondwing. Implants in accordance with the present invention are not intendedto be limited to those described in detail herein.

Materials for Use in Implants of the Present Invention

In some embodiments, the implant, and components of the implant (i.e.,the spacer, the distraction guide, etc.) can be fabricated from medicalgrade metals such as titanium, stainless steel, cobalt chrome, andalloys thereof, or other suitable implant material having similar highstrength and biocompatible properties. Additionally, the implant can beat least partially fabricated from a shape memory metal, for exampleNitinol, which is a combination of titanium and nickel. Such materialsare typically radiopaque, and appear during x-ray imaging, and othertypes of imaging. Implants in accordance with the present invention,and/or portions thereof can also be fabricated from somewhat flexibleand/or deflectable material. In these embodiments, the implant and/orportions thereof can be fabricated in whole or in part from medicalgrade biocompatible polymers, copolymers, blends, and composites ofpolymers. A copolymer is a polymer derived from more than one species ofmonomer. A polymer composite is a heterogeneous combination of two ormore materials, wherein the constituents are not miscible, and thereforeexhibit an interface between one another. A polymer blend is amacroscopically homogeneous mixture of two or more different species ofpolymer. Many polymers, copolymers, blends, and composites of polymersare radiolucent and do not appear during x-ray or other types ofimaging. Implants comprising such materials can provide a physician witha less obstructed view of the spine under imaging, than with an implantcomprising radiopaque materials entirely. However, the implant need notcomprise any radiolucent materials.

One group of biocompatible polymers is the polyaryletherketone groupwhich has several members including polyetheretherketone (PEEK), andpolyetherketoneketone (PEKK). PEEK is proven as a durable material forimplants, and meets the criterion of biocompatibility. Medical gradePEEK is available from Victrex Corporation of Lancashire, Great Britainunder the product name PEEK-OPTIMA. Medical grade PEKK is available fromOxford Performance Materials under the name OXPEKK, and also fromCoorsTek under the name BioPEKK. These medical grade materials are alsoavailable as reinforced polymer resins, such reinforced resinsdisplaying even greater material strength. In an embodiment, the implantcan be fabricated from PEEK 450G, which is an unfilled PEEK approved formedical implantation available from Victrex. Other sources of thismaterial include Gharda located in Panoli, India. PEEK 450G has thefollowing approximate properties: Property Value Density  1.3 g/ccRockwell M  99 Rockwell R 126 Tensile Strength  97 MPa Modulus ofElasticity  3.5 GPa Flexural Modulus  4.1 GPaPEEK 450G has appropriate physical and mechanical properties and issuitable for carrying and spreading a physical load between the adjacentspinous processes. The implant and/or portions thereof can be formed byextrusion, injection, compression molding and/or machining techniques.

It should be noted that the material selected can also be filled.Fillers can be added to a polymer, copolymer, polymer blend, or polymercomposite to reinforce a polymeric material. Fillers are added to modifyproperties such as mechanical, optical, and thermal properties. Forexample, carbon fibers can be added to reinforce polymers mechanicallyto enhance strength for certain uses, such as for load bearing devices.In some embodiments, other grades of PEEK are available and contemplatedfor use in implants in accordance with the present invention, such as30% glass-filled or 30% carbon-filled grades, provided such materialsare cleared for use in implantable devices by the FDA, or otherregulatory body. Glass-filled PEEK reduces the expansion rate andincreases the flexural modulus of PEEK relative to unfilled PEEK. Theresulting product is known to be ideal for improved strength, stiffness,or stability. Carbon-filled PEEK is known to have enhanced compressivestrength and stiffness, and a lower expansion rate relative to unfilledPEEK. Carbon-filled PEEK also offers wear resistance and load carryingcapability.

As will be appreciated, other suitable similarly biocompatiblethermoplastic or thermoplastic polycondensate materials that resistfatigue, have good memory, are flexible, and/or deflectable, have verylow moisture absorption, and good wear and/or abrasion resistance, canbe used without departing from the scope of the invention. As mentioned,the implant can be comprised of polyetherketoneketone (PEKK). Othermaterial that can be used include polyetherketone (PEK),polyetherketoneetherketoneketone (PEKEKK), polyetheretherketoneketone(PEEKK), and generally a polyaryletheretherketone. Further, otherpolyketones can be used as well as other thermoplastics. Reference toappropriate polymers that can be used in the implant can be made to thefollowing documents, all of which are incorporated herein by reference.These documents include: PCT Publication WO 02/02158 A1, dated Jan. 10,2002, entitled “Bio-Compatible Polymeric Materials;” PCT Publication WO02/00275 A1, dated Jan. 3, 2002, entitled “Bio-Compatible PolymericMaterials;” and, PCT Publication WO 02/00270 A1, dated Jan. 3, 2002,entitled “Bio-Compatible Polymeric Materials.” Other materials such asBionate®, polycarbonate urethane, available from the Polymer TechnologyGroup, Berkeley, Calif., may also be appropriate because of the goodoxidative stability, biocompatibility, mechanical strength and abrasionresistance. Other thermoplastic materials and other high molecularweight polymers can be used.

Methods for Implanting Interspinous Implants

A minimally invasive surgical method for implanting an implant 300 asshown in FIGS. 2A-8 in the cervical spine is disclosed and taughtherein. In this method, as shown in FIG. 14, preferably a guide wire 780is inserted through a placement network 790 into the neck of the implantrecipient. The guide wire 780 is used to locate where the implant 300 isto be placed relative to the cervical spine, including the spinousprocesses. Once the guide wire 780 is positioned with the aid of imagingtechniques, an incision is made on the side of the neck so that animplant 300 in accordance with an embodiment of the present invention,can be positioned in the neck thorough an incision and along a line thatis about perpendicular to the guide wire 780 and directed at the end ofthe guide wire 780. The main body 301 of the implant 300 is insertedinto the neck of the patient. Preferably during insertion, thedistraction guide 310 pierces or separates the tissue without severingthe tissue.

Once the main body 301 is satisfactorily positioned, an insert 370 canbe positioned within a cavity of the main body 301, causing thedistraction guide 310 of the main body 301 to be arranged in a secondconfiguration so that at least a portion of the distraction guide 310forms a second wing. The insert 370 can be inserted along a line that isgenerally colinear with the line over which the main body 301 isinserted. The anatomy of the neck is such that it is most convenient andminimally invasive to enter the neck from the side with respect to themain body 301 and the insert 370.

Further, a minimally invasive surgical method for implanting an implantas described in FIGS. 2A-8 in the lumbar spine is disclosed and taughtherein. In this method, as shown in the flowchart of FIG. 15A,preferably a unilateral incision or opening can be made using aposterior-anterior approach (Step 102). The unilateral incision can bemade, for example, at a location some distance to the left of an axisalong the spinous process. The incision or opening can be enlarged, anda distraction tool can be positioned within the incision so that theproximal end of the distraction tool (Step 104) can access an exposedside of the interspinous ligament. The distraction tool can be urgedthrough the interspinous ligament, thereby distracting the interspinousligament so as to receive the implant (Step 106). Once the interspinousligament is sufficiently distracted, the distraction tool can bedisengaged and removed from the incision (Step 108).

Once the distraction tool has been removed from the incision, theimplant can be positioned at the dilated opening, and the distractionguide of the implant can be urged through the dilated opening (Step110). The implant can be further urged through the opening until thespacer is positioned as desired between the adjacent spinous processesof the targeted motion segment (Step 112). The spacer is free to rotateso that the load is distributed more evenly over the surface of thespinous processes. Optionally, the implant can be urged through thedilated opening until the first wing contacts the adjacent spinousprocesses, thereby blocking further movement in the direction ofinsertion. Once the implant is properly arranged, the insert can bepositioned at the distal end of the implant so that the insert can beurged into and through the hollow cavity of the hollow central body(Step 114). As the insert is seated inside of the cavity, thedistraction guide splits, and the upper winglet and the lower wingletdeploy as a second wing. The remaining tools can be removed from theincision, and the incision can be closed (Step 116). Preferably duringinsertion, the distraction end pierces or separates the tissue withoutsevering the tissue.

Further, a minimally invasive surgical method for implanting an implantas shown in FIGS. 9A-13 in the lumbar spine is disclosed and taughtherein. In this method, as shown in the flowchart of FIG. 15B, anincision or opening can be made using a posterior-anterior approach(Step 202). The incision or opening can be enlarged, and a distractiontool can be positioned within the incision so that the proximal end ofthe distraction tool (Step 204) can access an exposed side of theinterspinous ligament. The distraction guide can be urged through theinterspinous ligament and distracted, thereby distracting theinterspinous ligament so as to receive the implant (Step 206). Once theinterspinous ligament is sufficiently distracted, the distraction toolcan be disengaged and removed from the incision (Step 208).

Once the distraction guide has been removed from the incision, theimplant can be positioned at the dilated opening, and the distractionguide of the implant can be urged through the dilated opening (Step210). The implant can be further urged through the opening until thespacer is positioned as desired between the adjacent spinous processesof the targeted motion segment (Step 212). The spacer is free to rotateso that the load is distributed more evenly over the surface of thespinous processes. Optionally, the implant can be urged through thedilated opening until the first wing contacts the adjacent spinousprocesses, thereby blocking further movement in the direction ofinsertion. Once the implant is properly arranged, an actuation tool canbe inserted within the incision at an opposite side of the adjacentspinous processes from the point of insertion (Step 214). The actuationtool can engage the actuation arrangement, and can actuate the actuationarrangement so that the upper winglet and the lower winglet deploy as asecond wing, as described above (Step 216). The remaining tools can beremoved from the incision, and the incision can be closed (Step 218).Preferably during insertion, the distraction end pierces or separatesthe tissue without severing the tissue.

The foregoing description of the present invention have been presentedfor purposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise forms disclosed.Many modifications and variations will be apparent to practitionersskilled in this art. The embodiments were chosen and described in orderto best explain the principles of the invention and its practicalapplication, thereby enabling others skilled in the art to understandthe invention for various embodiments and with various modifications asare suited to the particular use contemplated. It is intended that thescope of the invention be defined by the following claims and theirequivalents.

1. An interspinous implant adapted to be inserted between spinousprocesses, the implant comprising: a spacer; a distraction guide havinga first configuration; wherein the distraction guide is adapted to bearranged in a second configuration; and wherein when the distractionguide is arranged in the second configuration, the distraction guidelimits movement of the interspinous implant when positioned betweenspinous processes.
 2. The implant of claim 1, further including a firstwing; and wherein the spacer is disposed between the first wing and thedistraction guide.
 3. The implant of claim 1, wherein: the spacerincludes a cavity; and the implant further includes: an insert adaptedto be urged into the cavity; and wherein when the insert is urged intothe cavity, the distraction guide is arranged from the firstconfiguration to the second configuration.
 4. The implant of claim 3,wherein the insert includes an upper wing portion and a lower wingportion.
 5. The implant of claim 1, wherein: the distraction guideincludes: a first winglet pivotably associated with the spacer; a firstprotuberance extending from the first winglet; a second wingletpivotably associated with the spacer; and a second protuberanceextending from the second winglet; and the distraction guide is arrangedin a second configuration by applying a force to the first protuberanceand the second protuberance so that the first winglet and the secondwinglet pivot away from each other.
 6. The implant of claim 1, wherein:the distraction guide includes a first winglet and a second winglet; thesecond winglet is pivotably associated with the spacer; wherein thedistraction guide is arranged in a second configuration by urging thesecond winglet to pivot away from the first winglet.
 7. The implant ofclaim 1, wherein: the distraction guide includes: a first portionpivotably associated with one of the distraction guide and the spacer, afirst protuberance extending from the first portion, a second portionpivotably associated with one of the distraction guide and the spacer,and a second protuberance extending from the second portion; and thedistraction guide is arranged in a second configuration by applying aforce to the first protuberance and the second protuberance so that thefirst portion and the second portion pivot away from each other.
 8. Aninterspinous implant adapted to be inserted between spinous processes,the implant comprising: a first wing; a spacer extending from the firstwing; a distraction guide extending from the spacer; and wherein atleast one winglet of the distraction guide is adapted to be pivoted suchthat the distraction guide is a second wing.
 9. The implant of claim 8,wherein when the distraction guide is the second wing, the distractionguide limits movement of the interspinous implant when positionedbetween spinous processes.
 10. The implant of claim 8, furthercomprising: a cavity disposed through the first wing and the spacer; aninsert adapted to be urged into the cavity.
 11. The implant of claim 10,wherein when the insert is urged into the cavity, the distraction guideis pivoted.
 12. The implant of claim 8, wherein: the distraction guideincludes: a first winglet pivotably associated with the spacer; a firstprotuberance extending from the first winglet; a second wingletpivotably associated with the spacer; and a second protuberanceextending from the second winglet; and the distraction guide is pivotedby applying a force to the first protuberance and the secondprotuberance so that the first winglet and the second winglet pivot awayfrom each other.
 13. The implant of claim 8, wherein: the distractionguide includes a: a first section pivotably associated with one of thedistraction guide and the spacer; a first protuberance extending fromthe first section; a second section pivotably associated with one of thedistraction guide and the spacer; and a second protuberance extendingfrom the second section; and the distraction guide is pivoted byapplying a force to the first protuberance and the second protuberanceso that the first section and the second section pivot away from eachother.
 14. A method for insertion of an interspinous implant betweenspinous processes comprising the steps of: accessing first and secondspinous processes; inserting a main body between the spinous processes,which main body includes a spacer, a distraction guide arranged in afirst configuration, and a cavity disposed within the spacer; insertingan insert into the cavity in order to cause the distraction guide to bearranged in a second configuration.
 15. An interspinous implant adaptedto be inserted between spinous processes, the implant comprising: aspacer including a cavity; a distraction guide associated with thespacer and arranged in a first configuration; an inset adapted to beurged into the cavity; wherein when the insert is urged into the cavity,the distraction guide is arranged from the first configuration to thesecond configuration.
 16. The implant of claim 15, further including afirst wing.
 17. The implant of claim 15, wherein the insert includes anupper wing portion and a lower wing portion.
 18. The implant of claim15, wherein: the distraction guide includes: a first winglet pivotablyassociated with the spacer; a first protuberance extending from thefirst winglet; a second winglet pivotably associated with the spacer;and a second protuberance extending from the second winglet; and thedistraction guide is arranged in the second configuration by applying aforce to the first protuberance and the second protuberance so that thefirst winglet and the second winglet pivot away from each other.
 19. Theimplant of claim 1, wherein the distraction guide includes a distractionend and a wing pivotably mounted to the distraction guide rewardly ofsaid distraction end.
 20. The implant of claim 19, wherein the wing ispivoted from a first position adjacent to the distraction end to asecond position away from the distraction end.